Bioethics Meets R&D: The Ethics of Pre-approval Access
The Division of Medical Ethics at NYU School of Medicine and the Academy bring together patients, regulators, manufacturers, journalists, and experts to debate the difficult ethical issues surrounding “compassionate use” of pre-approved medicines.
Patients with life-threatening illnesses face challenges in accessing potential therapies at the cutting-edge of R&D which have not yet been proven in a clinical trial. Some pharmaceutical companies produce and provide medicines on a case-by-case basis through expanded access or "compassionate use" programs. The tension among principles of fairness, equity, and compassion are explored in this podcast through a case study about a social media campaign led to an expedited clinical trial for an investigative antiviral medicine. Guests will explore the provocative and emotional stories of patients, family members, advocates, researchers, physicians, and the regulators charged with keeping medicines in the marketplace safe and effective.